Protocol summary

Study aim
Comparison of the effect of tecar with low power laser after ten sessions of intervention and follow up three month after intervention on neurological symptoms and quality of life of peripheral neuropathy type2 diabetes
Design
intervention groups with parallel and randomized simple blocked groups in a double-blind manner on 15 people in each group
Settings and conduct
45 male and female patients typ2 diabetes will be performed in the physiotherapy clinic of the faculty of rehabilitation,shahid beheshti University of medical sciences,it will be done in a simple randomized block and double blind method,10sessions, 3 times a week.the evaluator and the therapist( researcher) are blinded
Participants/Inclusion and exclusion criteria
^Entry criteria: over50 years old, with at least 6 months of peripheral neuropathy symptoms of type2 diabetes,at least a score of 4 out of 10 on the pain visual analog scale, nerve conduction velocity tibial nerve< 40, body mass index< 30, and glycosylated hemoglobin<8.5 Non entry criteria: chronic kidney,lung diseases and peripheral vascular problems, presence of knee prosthesis and metal plate in the lower limb, pregnancy,addiction to drugs alcohol and smoking
Intervention groups
1- Tecar on + Laser on Italian New Age capacitor with a frequency of 250KHz and Power of 300 Watts and an output intensity <50%, is used Mustang 2000 Russian Laser, with two infrared wavelengths of 890 nanometer, out put power of 15 watts puls, frequency of 80 Hz and wavelength of 630nm red light, out put power 10 miliwatts, continious 2- Tecar on+ laser off As in the first group, the same methods are performed but with the Laser off 3- Laser on+ Tecar off As in the first group, the same methods are performed but with the Tecar off
Main outcome variables
Pain, Nerve conduction velocity, Tactile soles of the foot, Ankle Brachial Index, time up and go, Mishigan Questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221105056408N1
Registration date: 2022-12-22, 1401/10/01
Registration timing: prospective

Last update: 2022-12-22, 1401/10/01
Update count: 0
Registration date
2022-12-22, 1401/10/01
Registrant information
Name
Mitra Javan Amoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4422 4357
Email address
javanamoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Tecar with Low Level Laser in improving neurological symptoms and Quality of life in lower extremity Peripheral Neuropathy in type2 diabetes patients
Public title
Comparison the Effect of Tecar with Low power laser on peripheral neuropathy and quality of life in typ2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 50 years Diagnosis of type2 diabetes by endocrinologist and neurologist Minimum pain score of 4 based on visual analog scale(VAS) Body mass index < 30 Nerve conduction velocity(Ncv) < 40 tibial motor nerve Controlled blood sugar for last three months(Glycosylated hemoglobin Hba1c < 8.5)
Exclusion criteria:
The presence of symptoms of non diabetic neuropathy Systemic peripheral vascular involvement Pregnancy Patients with malignant tumors Chronic coronary artery,lung and kidney diseases Patients with pacemakers or mechanical insulin pumps Patient with knee joint teplacement and the presence of metal plaque in the lower limb Patients addicted to drugs, cigarettes and alcohol
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is a simple blocked method, we will have three groups of 15 people, each group will be assigned a code, and for each group, the code of the same group will be placed inside the closed envelope, and the patient will randoly choose an envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
The main researcher will not divide the samples into two groups and this work will be done by the research assistant who is a physiotherapy expert. Also, the evaluator will not know about the grouping of people. Also, the intervention is done by another person and the evaluation before and after the treatment is done by the main researcher.
Placebo
Not used
Assignment
Parallel
Other design features
The clinical trial has3 intervention groups with parallel groups and simple block randomization on 15 people in each group

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti university of Medical Sciencesof medical sciences
Street address
No.10, Abazar4 alley, Moallem Street, Amol Town
City
Amol
Province
Mazandaran
Postal code
4615798356
Approval date
2021-04-11, 1400/01/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.122

Health conditions studied

1

Description of health condition studied
Peripheral neuropathy of the lower limb of type2 diabetes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
Before, after10 session and 3month after intervention
Method of measurement
Visual analogue scale (numerical)(VAS)

2

Description
Nerve conduction velocity, tibial motor nerve
Timepoint
Before, after10 session and 3month after intervention
Method of measurement
Electromyography device

3

Description
The feeling of tactile soles of the foot
Timepoint
Before, after10 sessions and 3month after intervention
Method of measurement
By Sims Weinstein 10g monofilament ten points on the soles of the feet will be evaluated

4

Description
Mishigan questionnaire
Timepoint
Before, after10 sessions and 3month after intervention
Method of measurement
The questionnaire has two parts, one part evaluates and records by evaluator and the other part fills by patient

5

Description
Ankle brachial index, it is the ratio of ankle systolic blood pressure to arm systolic blood pressure
Timepoint
Before, after10 sessions and 3month after intervention
Method of measurement
By digital sphygmomanometer

6

Description
Sensory Sural nerve amplitude
Timepoint
Before, after10 sessions and 3month after intervention
Method of measurement
Electromyography device

Secondary outcomes

1

Description
Quality of life
Timepoint
Befor intervention and after three months10 session intervention
Method of measurement
Summary questionnaire of 26 questions of the World Health Organization

Intervention groups

1

Description
Intervention group: Tecar on + Laser off
Category
Treatment - Devices

2

Description
Intervention group: Tecar on + Laser on
Category
Treatment - Devices

3

Description
Intervention group: Laser on + Tecar off
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital, Tehran
Full name of responsible person
Mitra Javan Amoli
Street address
N.10, Abazar4 alley, Moallem street, Amol Town
City
Amol
Province
Mazandaran
Postal code
4615798356
Phone
+98 11 4422 4357
Email
javanamoli@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Tehran, Shahid Chamran Highway, Yemen St., shahid Arabi St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Headquarters Building2, 5th Floor, Deputy of research and technology
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of researches and technology
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Javan Amoli
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
N. 10, Abazar alley 4, Moallem street, Amol Town
City
Amol
Province
Mazandaran
Postal code
4615798356
Phone
+98 11 4422 4357
Email
javanamoli@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Javan Amoli
Position
Associate Professor Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
N. 10, Abazar Alley 4, Moallem Street, Amol Town
City
Amol
Province
Mazandaran
Postal code
4615798356
Phone
+98 11 4422 4357
Email
javanamoli@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Javan Amoli
Position
Associate Professor Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
N. 10, Abazar Alley 4, Moallem Street, Amol Town
City
Amol
Province
Mazandaran
Postal code
4615798356
Phone
+98 11 4422 4357
Email
javanamoli@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All above will be published in article
When the data will become available and for how long
After the article publication
To whom data/document is available
Researchers and students in academic centers
Under which criteria data/document could be used
Other researchers and therapists in the reahabilitation and medical fild can use this study
From where data/document is obtainable
After the article publication, people can find the article by searching in internet and access the data
What processes are involved for a request to access data/document
After requesting the documents, the person in charge of the research project must receive a written permission from the university and after obtaining the permission, send the documents,so summary will be sent about 6 months after the request for this data
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